Status:
RECRUITING
Understanding and Treating Suicidal Ideation With Ketamine
Lead Sponsor:
The Royal's Institute of Mental Health Research
Conditions:
Suicidal Ideation
Major Depressive Disorder (MDD)
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
The goal of this clinical trial is to treat active suicidal ideation in individuals with Major Depressive Disorder (MDD) using ketamine and to understand suicidal ideation by examining biological mech...
Detailed Description
This innovative, mixed-method study will combine treatment, neuroimaging, and qualitative interview approaches in a clinical sample enriched for suicide-related outcomes and selected for the presence ...
Eligibility Criteria
Inclusion
- English speaking
- Ages 18-65 years old
- Suicidal ideation severity score ≥3 on the Columbia Suicide Severity Rating Scale (C-SSRS) (Baseline/Screening version) at Screening Visit ("active suicidal ideation with any methods")
- Diagnosis of Major Depressive Disorder (MDD) according to the Diagnostic and Statistical Manual for Mental Disorders 5th Edition (DSM-5)
- Willing to maintain stable doses of concomitant medications throughout the study
- Be under the care of a designated health care provider (i.e., family physician or psychiatrist) to follow their care after the completion of the study.
Exclusion
- Participants not medically cleared to receive ketamine treatment due to presence of clinically relevant disease (e.g., uncontrolled hypertension, renal or hepatic impairment, significant coronary artery disease, diabetes mellitus, seizure disorder).
- Known or suspected hypersensitivity or intolerance to ketamine
- Body mass index (BMI) ≥35
- History of a primary psychotic disorder (e.g., schizophrenia), or current or recent (\<2 years) acute episode of psychosis
- Current and/or recent history (\<12 months) of substance use/dependence (except for caffeine or nicotine) or problematic current alcohol use or dependence as defined by DSM-5 criteria
- Pregnant, breastfeeding or of childbearing potential and unwilling to use an approved method of contraception during the study
- History of significant head injury including loss of consciousness \>5 minutes
- Any MRI contraindications
- Concurrent use of ketamine in any form
- Concurrent active ECT or repetitive transcranial magnetic stimulation (rTMS) therapy
Key Trial Info
Start Date :
April 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06891300
Start Date
April 8 2025
End Date
October 1 2026
Last Update
April 11 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Royal Ottawa Mental Health Centre
Ottawa, Ontario, Canada, K1Z7K4